Mp13-15 Molecular Urine Cytology – Bladder Epicheck Is a Novel Molecular Diagnostic Tool for Monitoring of Bladder Cancer Patients

Wasserstrom, Adam; Frumkin, Danny; Dotan, Zohar; Bukin, Elena; Gadish, Tal; Hanuka, Shiri; Knirsh, Revital; Darawsha, Abd Elhalim; Leibovitch, Ilan

doi:10.1016/j.juro.2016.02.2496

Cited by 22 publications

(30 citation statements)

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“…The high NPV reported by previous studies could not be reached in our study (97%, 95.1%, and 94.4% vs 82.9%, respectively). The PPV in our study was superior to that reported by Witjes et al (68.2% vs 48.8%) but was not reported by Wassermann et al and thus cannot yet be discussed.…”

Section: Discussioncontrasting

confidence: 99%

“…The specificity reported by Wasserstrom et al was 83%, and that in the studies by Witjes et al and D'Andrea et al was 88%, whereas the specificity in our study was 86.3%. However, the test could not reach the excellent specificity of cytology (98%) but nonetheless performed in an excellent way.…”

Section: Discussioncontrasting

confidence: 63%

“…The Bladder EpiCheck test is a newly developed urinary marker based on DNA methylation changes associated with BC in a panel of 15 genomic biomarkers. The validation study showed a sensitivity of 90%, a specificity of 83%, and an NPV of 97% in 222 patients with NMIBC who were under surveillance …”

Section: Discussionmentioning

confidence: 98%

“…The validation study showed a sensitivity of 90%, a specificity of 83%, and an NPV of 97% in 222 patients with NMIBC who were under surveillance. 14 There are 2 recent studies. The study by Witjes et al 15 included 440 patients and showed a drop-out rate of 8.4%, an overall sensitivity of 68.2%, and a specificity of 88%; and the other study, by D'Andrea et al, 16 also included 440 patients and showed an overall sensitivity of 67.3% and a specificity of 88%.…”

Section: Cancer Cytopathology July 2019mentioning

confidence: 99%

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Diagnostic predictive value of the Bladder EpiCheck test in the follow‐up of patients with non–muscle‐invasive bladder cancer

Trenti

D’Elia

Mian

et al. 2019

Cancer Cytopathology

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Background The objective of this study was to evaluate the diagnostic accuracy of the Bladder EpiCheck test in the follow‐up of patients with non–muscle‐invasive bladder cancer (NMIBC) and to compare it with the accuracy of urinary cytology, cystoscopy, and/or histology. Methods In total, 243 patients were enrolled in the current study. Patients were evaluated by voided urine cytology, by the Bladder EpiCheck test, and by white‐light cystoscopy. Results Overall sensitivity was 33.3% for cytology, 62.3% for Bladder EpiCheck, and 66.7% for the 2 tests combined. The sensitivity of cytology increased from 7.7% in low‐grade (LG) tumors to 66.6% in high‐grade (HG) tumors; whereas, for the Bladder EpiCheck test, the sensitivity was 46.1% in LG tumors and 83.3% in HG tumors. Combined cytology and Bladder EpiCheck testing yielded an overall sensitivity of 56.4% for LG tumors and 90% for HG tumors. Overall specificity was 98.6% for cytology, 86.3% for Bladder EpiCheck, and 85.6% for the 2 tests combined. The positive predictive value was 92% for cytology and 68.2% for Bladder EpiCheck. For the 2 tests combined, it was 68.6%. The negative predictive value was similar for the 2 tests: 75.8% for cytology, 82.9% for Bladder EpiCheck, and 84.5% for the 2 tests combined. Conclusions The sensitivity of the Bladder EpiCheck test was significantly higher than that of cytology. The test performed very well in terms of specificity but could not reach the high value of cytology. The positive predictive value was higher for Bladder EpiCheck, whereas the negative predictive value was approximately the same for both tests.

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Section: Discussioncontrasting

confidence: 99%

Section: Discussioncontrasting

confidence: 63%

Section: Discussionmentioning

confidence: 98%

Section: Cancer Cytopathology July 2019mentioning

confidence: 99%

See 2 more Smart Citations

Diagnostic predictive value of the Bladder EpiCheck test in the follow‐up of patients with non–muscle‐invasive bladder cancer

Trenti

D’Elia

Mian

et al. 2019

Cancer Cytopathology

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show abstract

“…The validation study by Wasserstrom et al [15] applied BE on a sample population of 222 patients. Histological diagnosis of bladder cancer was possible for 40 patients (18%), and BE correctly identified 36 malignancies, with an overall sensitivity of 90%.…”

Section: Results: Sensitivity Specificity and Predictive Values Anamentioning

confidence: 99%

The Bladder EpiCheck Test as a Non-Invasive Tool Based on the Identification of DNA Methylation in Bladder Cancer Cells in the Urine: A Review of Published Evidence

Mancini

Righetto

Zumerle

et al. 2020

IJMS

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Recently, there has been a great effort to develop tests based on non-invasive urinary biomarkers (NMIBCs). These tests are based on the fact that NMIBCs are heterogeneous at the molecular level and can be divided into different molecular groups useful to predict prognosis and response to treatment. The assessment of epigenetic alterations, such as DNA methylation, represents a promising cancer biomarker. DNA methylation is an epigenetic modification that affects gene expression without modifying the DNA sequence. Several studies have highlighted the presence of methylated loci in the context of bladder cancer, indicating its potential application as a diagnostic and prognostic biomarker. One of the novel assays based on a DNA methylation profile, the Bladder EpiCheck, analyzes DNA from spontaneous urine, detecting disease-specific DNA methylation patterns in bladder cancer patients. This test, due to its non-invasive nature and highly promising performance could, in future, become an invaluable tool in the follow-up of bladder cancer patients. Potential new applications could include diagnosis and surveillance of upper-tract disease, for the replacement of invasive testing and ureteroscopy.

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Comparison of 2 new real‐time polymerase chain reaction–based urinary markers in the follow‐up of patients with non–muscle‐invasive bladder cancer

Trenti

Pycha

Mian

et al. 2020

Cancer Cytopathology

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BackgroundThe objective of the current study was to compare the diagnostic accuracy of 2 new real‐time polymerase chain reaction–based urinary markers with each other and with urinary cytology, cystoscopy, and/or histology in patients being followed for non–muscle‐invasive bladder cancer.MethodsA total of 487 patients were enrolled in the study. Patients were evaluated using voided urine cytology, the Xpert Bladder Cancer Monitor, the Bladder EpiCheck test, and white light cystoscopy.ResultsThe overall sensitivity was 27.17% for cytology, 64.13% for the Bladder EpiCheck test, and 66.3% for the Xpert Bladder Cancer Monitor. The overall specificity was 98.82% for cytology, 82.06% for the Bladder EpiCheck test, and 76.47% for the Xpert Bladder Cancer Monitor. The negative predictive value was very similar for the 3 tests at 83.56% for cytology, 89.42% for the Bladder EpiCheck test, and 89.35% for the Xpert Bladder Cancer Monitor. When combined, the Bladder EpiCheck test and Xpert Bladder Cancer Monitor detected overall 79.35% of the tumors: 70.37% in low‐grade and 92.11% in high‐grade tumors.ConclusionsThe Xpert Bladder Cancer Monitor and Bladder EpiCheck test were found to perform very well in terms of sensitivity. Together, the 2 tests detected approximately 92.11% of high‐grade tumors. Their specificity was high but could not reach the excellent value of cytology. The negative predictive value was the same for both tests and was higher than that for cytology, especially when the tests were used together (92.24%). These 2 new tests hold promise as urinary biomarkers. They may be used in combination to maximize sensitivity in a less invasive way, thereby reducing invasiveness in the follow‐up of patients with non–muscle‐invasive bladder cancer and decreasing discomfort for the patients as well as complications and costs.

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Mp13-15 Molecular Urine Cytology – Bladder Epicheck Is a Novel Molecular Diagnostic Tool for Monitoring of Bladder Cancer Patients

Cited by 22 publications

References 0 publications

Diagnostic predictive value of the Bladder EpiCheck test in the follow‐up of patients with non–muscle‐invasive bladder cancer

Diagnostic predictive value of the Bladder EpiCheck test in the follow‐up of patients with non–muscle‐invasive bladder cancer

The Bladder EpiCheck Test as a Non-Invasive Tool Based on the Identification of DNA Methylation in Bladder Cancer Cells in the Urine: A Review of Published Evidence

Comparison of 2 new real‐time polymerase chain reaction–based urinary markers in the follow‐up of patients with non–muscle‐invasive bladder cancer

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